Associate Director, Analytical Development (Biologics)
South San Francisco, California, United States
USD 172K-215K Mid-level Full Time
Tasks
- Author and review CMC sections for regulatory submissions
- Design and manage stability programs for drug substance and drug product
- Develop analytical strategies aligned with CMC stage and regulatory expectations
- Develop validate and transfer analytical methods for biologics
- Oversee contract laboratories and external analytical activities
- Partner with process development manufacturing quality assurance and regulatory affairs
- Provide technical oversight for reference standards starting materials intermediates release testing stability testing drug substance and drug product
- Support out of specification results deviations non conformance investigations and CAPA
Perks/Benefits
- N/A
Skills/Tech-stack
Analytical Chemistry | Binding assays | Biologics CMC | CE-SDS | CGMP | DNA Testing | HCP Testing | HPLC | IEX chromatography | IcIEF | Impurity testing | LCMS | Method transfer | Method validation | Potency assays | Protein A | Quality Systems | RP chromatography | Regulatory Submissions | Residual Protein A | SEC | Stability Studies | UHPLC
Education
Regions
Countries
States
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